Study to Determine the Safety, Tolerability and Pharmacokinetics of UV-4B Solution Administered Orally in Healthy Subjects

• Status: Completed
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective is to evaluate the safety and tolerability of a single-ascending oral dose of UV-4B in healthy subjects and to determine pharmacokinetic parameters describing absorption and elimination following a single dose of UV-4B in healthy subjects.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Unither Virology
• Collaborators: Emergent BioSolutions; Quintiles, Inc.
• Treatments: Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• Healthy subjects

• Women: non-pregnant, non-lactating; if of childbearing potential, on specified contraception measures during the study period

• Men: using barrier contraception measures during the study period

Exclusion Criteria:

• Health conditions

• Taking prescription and non-prescription drugs (exceptions: acetaminophen, vitamins, hormonal birth control)